(责任编辑：宋政 HN002) | 代码 | 名称 | 最新价 | 涨跌幅 ^ | | --- | --- | --- | --- | | 02410 | 同淵康医药-B ● | 14.700 | -21.97% | | 01672 | 歌礼制药-B | 13.850 | -10.76% | | 09969 | 诺诚健华 | 18.230 | -8.21% | | 03692 | 翰森制药 | 35.780 | -7.83% | | 02157 | 乐普生物-B | 8.870 | -7.70% | | 09926 | 康方生物 | 160.200 | -6.86% | | 02162 | 康诺亚-B | 70.200 | -6.09% | | ૦૯૭૨૨ | 博安生物 | 15.100 | -5.98% | | 06990 | 科伦博泰生物-B | 431.400 | -5.39% | | 01477 | 欧康维视生物-B | 11.350 | -5.02% | | 02196 | 复是医药 | 20.500 | -4.92% | | 00460 | 四环医药 | 1.420 | -4.70% | 盘面上， ...

Core Viewpoint - Tongyuan Kang Pharmaceutical-B (02410) experienced a significant stock price increase, attributed to the acceptance of its innovative drug, TY-9591, for a key II phase registration clinical trial report at the 2025 World Lung Cancer Conference (WCLC) [1] Group 1: Company Developments - The company announced that its self-developed innovative drug, TY-9591, targets EGFR mutation-type non-small cell lung cancer (NSCLC) and has shown promising results in clinical trials [1] - TY-9591 is a highly selective small molecule inhibitor aimed at addressing unmet clinical needs for NSCLC patients with brain metastases under current treatment standards [1] Group 2: Clinical Trial Results - Research indicates that TY-9591, as a new generation EGFR-TKI, demonstrates superior efficacy in controlling brain metastases and alleviating symptoms, potentially offering a new and more effective first-line treatment option for EGFR mutation NSCLC patients with brain metastases [1]

Group 1 - The core viewpoint of the article highlights the positive impact of rising expectations for interest rate cuts in the US on the biotechnology sector, leading to a significant increase in the S&P Biotechnology Index by 2.89% [1] - The Hong Kong pharmaceutical sector continues to show strong performance, with the Hong Kong Pharmaceutical ETF (159718.SZ) rising by 0.38% [1] - Notable individual stock performances include a 6.22% increase for Simcere Pharmaceutical Group (02410), a 3.34% rise for BeiGene (06160), and a 2.29% increase for Kelun-Biotech (06990) [1] Group 2 - The liquidity in the market is robust, with the Hong Kong Pharmaceutical ETF seeing a turnover of 13.3% and a transaction volume of 36.42 million yuan within the first 20 minutes of trading [1] - Guotai Junan Securities has stated that China's innovative drugs are on the rise, entering the initial phase of realizing innovation results, with significant opportunities for independent development and large transactions through business development (BD) licensing [1] - The Hong Kong Pharmaceutical ETF focuses on 18 A-share biotechnology companies, including key innovative drug firms such as BeiGene, WuXi Biologics, and CSPC Pharmaceutical Group, benefiting from global innovation drug research dividends [1] Group 3 - The article emphasizes the favorable conditions for the innovative drug growth sector due to the anticipated US interest rate cuts, which are expected to benefit the domestic innovative drug companies as they expand internationally [1] - The recommendation is to pay attention to the Hong Kong Pharmaceutical ETF (159718.SZ) and its associated funds (Class A: 019598, Class C: 019599) as they are positioned to capitalize on these trends [1]

Core Viewpoint - Tongyuan Kang Pharmaceutical-B (02410) experienced a significant stock price increase, attributed to the acceptance of its innovative drug, Aditinib (TY-9591), for a key Phase II registration clinical trial in treating EGFR-mutant non-small cell lung cancer (NSCLC) [1] Company Summary - The company's stock rose over 10% in early trading and is currently up 4.78%, priced at 18.2 HKD with a trading volume of 32.2051 million HKD [1] - Aditinib (TY-9591) is a highly selective small molecule inhibitor targeting classic EGFR gene mutations, aimed at addressing unmet clinical needs in NSCLC patients with brain metastases [1] - The drug has shown excellent efficacy in controlling brain metastases and alleviating symptoms, potentially offering a new and more effective first-line treatment option for EGFR-mutant NSCLC patients with brain metastases [1] Industry Summary - The acceptance of the clinical trial results at the 2025 World Lung Cancer Conference (WCLC) highlights the ongoing advancements in targeted therapies for lung cancer, particularly for patients with specific genetic mutations [1] - The focus on brain metastases in NSCLC treatment reflects a growing recognition of the need for effective therapies in this challenging area of oncology [1]

消息面上，同源康医药表示，自主研发的创新药物艾多替尼片(TY-9591)治疗EGFR变异型非小细胞肺癌 (NSCLC)的关键性II期注册临床试验结果，已在国际肺癌研究协会(IASLC)举办的2025年世界肺癌会议 (WCLC)上被接受为minioral报告(MA08.06)，并将在会议期间进行专题汇报。 公告称，艾多替尼片(TY-9591)是公司开发的高选择性小分子抑制剂，以经典EGFR基因突变为靶点，旨 在满足在当前治疗标准下对非小细胞肺癌脑转移瘤尚未得到满足的临床需求。研究表明，艾多替尼作为 研发的新一代EGFR-TKI，对控制脑转移病灶和缓解病情显示优异的疗效，有望为伴脑转移的EGFR突 变NSCLC患者提供新的、更有效的一线治疗选择。 智通财经APP获悉，同源康医药-B(02410)早盘涨超10%，截至发稿，涨4.78%，报18.2港元，成交额 3220.51万港元。 ...

本次入选mini oral的ESAONA关键试验是一项开放标签、多中心、随机II期研究，重点关注具有EGFR突 变(L858R或19Del)和脑转移的患者，旨在比较艾多替尼(160mg，每日一次)对比奥希替尼(80mg，每日一 次)在未经治疗的EGFR敏感突变且伴脑转移的NSCLC患者中的一线疗效和安全性。研究主要终点包 括：颅内客观缓解率(iORR)，颅内无进展生存期(iPFS)。次要终点包括：客观缓解率(ORR)，无进展生 存期(PFS)，总生存期(OS)，疾病控制率(DCR)，肿瘤缓解深度(DepOR)，安全性指标等。期中分析一共 进行两次，第一次于达到220例颅内病灶可评估病例时进行，第二次将于达到238例iPFS事件数时进行， 最终分析将于全部iPFS事件数达到后进行。如达到主要终点，第一次期中分析的数据用于向国家药监局 (NMPA)递交相关资料，申请有条件批准上市。最终完成数据分析将用于向NMPA申请艾多替尼片的完 全上市批准。 艾多替尼片(TY-9591)是同源康医药开发的高选择性小分子抑制剂，以经典EGFR基因突变为靶点，旨在 满足在当前治疗标准下对非小细胞肺癌脑转移瘤尚未得到满足的临床需求。 ...

本次入选mini oral的ESAONA关键试验是一项开放标签、多中心、随机II期研究，重点关注具有EGFR突 变(L858R或19Del)和脑转移的患者，旨在比较艾多替尼(160mg，每日一次)对比奥希替尼(80mg，每日一 次)在未经治疗的EGFR敏感突变且伴脑转移的NSCLC患者中的一线疗效和安全性。研究主要终点包 括：颅内客观缓解率(iORR)，颅内无进展生存期(iPFS)。次要终点包括：客观缓解率 (ORR)，无进展生 存期(PFS)，总生存期(OS)，疾病控制率(DCR)，肿瘤缓解深度 (DepOR)，安全性指标等。期中分析一共 进行两次，第一次于达到220例颅内病灶可评估病例时进行，第二次将于达到238例iPFS事件数时进行， 最终分析将于全部iPFS事件数达到后进行。如达到主要终点，第一次期中分析的数据用于向国家药监局 (NMPA)递交相关资料，申请有条件批准上市。最终完成数据分析将用于向NMPA申请艾多替尼片的完 全上市批准。 艾多替尼片(TY-9591)是同源康医药开发的高选择性小分子抑制剂，以经典EGFR 基因突变为靶点，旨 在满足在当前治疗标准下对非小细胞肺癌脑转移瘤尚未得到满足的临床 ...

同源康医药8月14日在港交所公告，公司自主研发的艾多替尼片（TY-9591）治疗EGFR变异型非小细胞 肺癌（NSCLC）的关键性II期注册临床试验（NCT05948813）结果，已在国际肺癌研究协会（IASLC） 举办的2025年世界肺癌会议（WCLC）上被接受为mini oral报告（MA08.06），并将在会议期间由主要 研究者北京医学科学院肿瘤医院的石远凯教授进行专题汇报。艾多替尼作为研发的新一代EGFR-TKI， 对控制脑转移病灶和缓解病情显示优异的疗效，有望为伴脑转移的EGFR突变NSCLC患者提供一线治疗 选择。公司无法确保能成功开发、上市及/或商业化TY-9591。 ...

Core Insights - The company, Tongyuan Kang Pharmaceutical-B (02410.HK), announced that its innovative drug, Aiduotini Tablets (TY-9591), for treating EGFR-mutated non-small cell lung cancer (NSCLC), has had its key Phase II registration clinical trial results accepted for a mini oral report at the 2025 World Lung Cancer Conference (WCLC) [1][2] - Aiduotini Tablets (TY-9591) is a highly selective small molecule inhibitor targeting classic EGFR gene mutations, aimed at addressing unmet clinical needs for brain metastases in NSCLC under current treatment standards [1] Study Details - The ESAONA key trial is an open-label, multi-center, randomized Phase II study focusing on patients with EGFR mutations (L858R or 19Del) and brain metastases, comparing the efficacy and safety of Aiduotini (160mg once daily) against Osimertinib (80mg once daily) in treatment-naive EGFR-sensitive mutation patients with brain metastases [2] - Primary endpoints include intracranial objective response rate (iORR) and intracranial progression-free survival (iPFS), while secondary endpoints encompass overall response rate (ORR), progression-free survival (PFS), overall survival (OS), disease control rate (DCR), depth of tumor response (DepOR), and safety indicators [2] - Interim analyses will occur twice: the first when 220 evaluable intracranial lesions are reached, and the second upon reaching 238 iPFS events, with final analysis conducted after all iPFS events are completed [2] - If primary endpoints are met, the first interim analysis data will be used to submit relevant materials to the National Medical Products Administration (NMPA) for conditional market approval, while the final data analysis will support the application for full market approval of Aiduotini Tablets [2]

TYK Medicines, Inc 浙江同源康醫藥股份有限公司 （於中華人民共和國註冊成立的股份有限公司） 香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何意見，並明確表示概不就因本公告全部或任何部分內容而產生或因倚賴 該等內容而引致的任何損失承擔任何責任。 （股份代號：2410） 自願性公告 EGFR靶向創新藥艾多替尼在腦轉移肺癌患者中展現突破性療效—— WCLC 2025公佈ESAONA關鍵註冊研究中期結果 本公告乃由浙江同源康醫藥股份有限公司（「本公司」或「同源康醫藥」，連同其附 屬公司統稱「本集團」）自願刊發，以告知本公司股東及潛在投資者有關本集團最 新業務發展的資料。 本公司董事（「董事」）會（「董事會」）欣然宣佈，其自主研發的創新藥物艾多替尼 片(TY-9591)治療EGFR變異型非小細胞肺癌(NSCLC)的關鍵性II期註冊臨床試驗 (NCT05948813)結果，已在國際肺癌研究協會(IASLC)舉辦的2025年世界肺癌會 議(WCLC)上被接受為mini oral報告(MA08.06)，並將在會議期間由主要研究者北 京醫學科學院腫瘤醫院 ...